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N/A N=86 Randomized Triple-blind Supportive Care

Behavioral Change Communication for Physical Activity Among Females With Type2 Diabetes Mellitus

Physical Inactivity · Type2 Diabetes Mellitus

Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention. — 216.07; 201.47 log calories/day — p=0.007

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Behavioral change communication model(BCC) to promote physical activity (Behavioral); pamphlet-The printed pamphlet,'Physical activity:To control blood sugar/ Diabetes Mellitus' (Other)
Age
Adult, Older Adult · 30+ yrs
Sex
Female
Sponsor
Thiruvananthapuram Medical College
Primary completion
Oct 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention.
216.07; 201.47 0.007 sig
PRIMARY
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
2.03; 4.48; 59.3; 30.6; 72.9; 46.6 0.053
SECONDARY
Glycosylated Haemoglobin(HbA1c)
6.0465; 6.0881 0.811

Summary

The marked discrepancy between predicted and actual prevalence of Type2 diabetes Mellitus (DM) with the actual cases rising earlier than expected, underscore the continuing relevance of tailored awareness and management strategies including physical activity(PA) to combat growing diabetes pandemic. Research is needed to develop effective programs that promote PA among female patients.Design& Method randomized controlled trial . 86 females 30 -65 years with type 2 DM attended Diabetic Clinic out patient at government tertiary care hospital,Kerala, south India from May to October 2006 including one week pilot study, participant selection, random allocation and intervention. Block randomized to intervention(43) and control(43) groups. Intervention-'Behavioral change communication model, including 30 mints 'PA promotion video',pamphlet and last week recall and report of PA using an interview schedule for 4 consecutive visits. measures- Total PA/day calculated in calorie from METs(metabolic equivalent score) , HbA1C, Total knowledge score, stage of change of behavior, the baseline PA under four domains in Metabolic Equivalent Task Score by interview using IPAQ(International Physiclal Activity Questionnaire) long form, body weight, occupation and source of water. Physical activity recommendations according to Centres for Disease Control and Prevention Atlanta guide lines- • Moderate intensity PA-30 mins./day(4-6.5 MET) for 5 days/week (brisk walk).Subjective assessment of moderate exercise - 1. talk test-One who is on a moderate intensity level should be able to carry on a conversation comfortable while engagement in the activity. 2. Vigorous intensity PA >6.5METs-Person will not be able to carry out conversation. running, aerobics for 20 mins

Eligibility Criteria

Inclusion Criteria

  • females 30to 65yrs. with type-2 Diabetes Mellitus.
  • Attending Diabetic clinic at a tertiary level hospital(medical college Thiruvananthapuram)
  • on oral hypoglycemics

Exclusion Criteria

  • only one patient from one family
  • H/o myocardial infarction
  • nephropathy
  • autonomic neuropathy
  • severe limiting osteo arthritis
  • pregnancy
  • Mental incompetence
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00690326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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